BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MAXIMA PRO 2L HP MINI HEAD F/O

    MDR report key: 19122839 · Received April 17, 2024

    Report

    Report Number
    3010364969-2024-00007
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    January 23, 2024
    Report Date
    April 17, 2024
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER DENTIST, THE MOTOR DIDN'T "BLOW UP", THE PUSH BUTTON ON THE TOP, IT HAD SEPARATED AND CAME APART DURING USE WHILE DOING A LOWER FILLING PROCEDURE. THE PATIENT WASN'T AWARE OF THE INCIDENT, AND THEY USED A DIFFERENT HANDPIECE. THE PATIENT WAS AN 82 YEAR OLD MALE AND NO MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893590 MAXIMA PRO 2L HP MINI HEAD F/O HANDPIECE EFB TTBIO CORP. MAXIMA PRO 2L HP MINI HEAD F/O 73088

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization